Tackling AMR requires global consensus and action on many fronts.
Creating an antimicrobial market that ensures adequate innovation, access, and stewardship is key to fighting AMR.
Improving infection prevention and control, increasing surveillance, and reducing antibiotic use in agriculture are also critical.
Progress has been made to garner political commitment to tackle AMR, including through high-level commitments at the 2015 World Health Assembly and the 2016 UN General Assembly.
More than 170 National Action Plans (NAPs) were developed to formalize government responses to AMR.
New R&D initiatives have been created (such as CARB-X, GARDP, and the AMR Action Fund), and some countries have started to pilot new ways to value and procure antibiotics, including the United Kingdom’s subscription model and Japan’s pilot for a revenue guarantee system.
Surveillance systems have been improved through the Fleming Fund, and better data for decision making are available via the R&D Hub.
These policies and commitments are laudable, but collective action problems still stand in the way of realizing a new international approach to the antimicrobial market.
Building on its previous research and analysis on AMR, in 2022, CGD launched the working group A New Grand Bargain to Improve the Antimicrobial Market for Human Health to examine policy options to drive global action against AMR.
We outline the principles of a Grand Bargain that we believe all stakeholders can and should sign up to during the UN General Assembly's High-Level Meeting on AMR in 2024.
Balancing antimicrobial innovation, access, and stewardship
The current market for antimicrobials fails to spur research and development (R&D), ensure access to new and existing products, and protect against overuse.
These three objectives—innovation, access, and stewardship—must be balanced to ensure sustainability and equity. Global commitment and action are needed to overcome collective action problems and realize a new market structure for antimicrobials.
Three factors needed for a sustainable antimicrobial market
Innovation, Access, and Stewardship
Three factors needed for a sustainable antimicrobial market
without stewardship, speeds resistance and undermines innovation
constrains access and undermines innovation without a balanced policy
unjust without access, wasteful without stewardship
The R&D pipeline for antimicrobials is—and for decades has been—dry.
The number of new antibiotics approved by the US Food and Drug Administration fell from 16 in 1983–87 to 3 in 2008–12—a decline of 81 percent.
Resistance buildup is outpacing innovation, and the innovation agenda does not sufficiently reflect the needs of low- and middle-income countries.
Methods to assess the value of antimicrobial treatments fail to adequately value all benefits derived from antimicrobials. As a result, renumeration is insufficient to encourage innovation, and market entry in many countries is limited.
Analysis conducted as part of this working group offers a new assessment framework that can integrate LMIC priorities, including affordability, accessibility, ease of administration, heat stability, and wide applicability.
Amidst persistent challenges, some recent positive developments have occurred in antimicrobial innovation. Payouts contingent on R&D success (“pull incentives”) have been piloted in the United Kingdom and Sweden and proposed in the United States, Japan, Canada, and the European Union. Estimates suggest that the domestic return on such investments would be as high as 28:1.
Further implementation of these mechanisms, coupled with higher levels of “push funding” (upfront funding for R&D) are needed to fill the significant remaining gaps in the innovation pipeline.
Alongside the moral imperative to expand access to essential medicines, widespread availability of essential treatments is needed to help decrease transmission and limit inappropriate use of other antimicrobials used when first-line treatments are inaccessible, reducing the risk of diseases spreading to the whole world.
Most antibiotics are off-patent. Manufacturers of these drugs face thin margins and minimal incentives to invest in supply chain flexibility and resiliency. Shortages of amoxicillin—a key off-patent medicine—were recorded in late 2022 and early 2023 in 80 percent of the 35 countries for which the World Health Organization (WHO) had data.
Greater supply chain resilience is needed, but collective action problems disincentivize procurers from paying the price.
Initiatives such as the partnership created by the pharmaceutical company Shionogi, the Global Antibiotic Research and Development Partnership (GARDP), and the Clinton Health Access Initiative (CHAI) to ensure the successful rollout of their novel antibiotic cefiderocol and efforts by the Global Drug Facility to roll out safe, effective, and affordable tuberculosis treatments provide lessons and potential models for future interventions to address access issues for off-patent and on-patent treatments.
The current market for antimicrobials contains structural failures and perverse incentives that undermine stewardship, contribute to higher levels of inappropriate use, and drive up resistance rates.
Stewardship refers to the appropriate use of antimicrobials to ensure that their efficacy is maintained over time.
Adequate stewardship measures must be imposed to support appropriate use of Reserve and Watch category drugs, as defined by the WHO’s AWaRe classification.
Prescription policies and reporting databases could be leveraged to strengthen stewardship, but they must allow countries sufficient flexibility to sustain and expand access to antibiotics at a level commensurate with local disease burden.
Countries need targets for antimicrobial usage that are measurable (to facilitate accountability) and absolute (so that they can be tailored to national circumstances).
from CGD’s working group A New Grand Bargain to Improve the Antimicrobial Market for Human Health
This report presents recommendations on increasing the availability of critically needed drugs, creating incentives to develop new ones, and reducing market pressures to misuse or oversell the drugs.
It provides one political and five operational recommendations.
The political recommendation outlines why it is both possible and in everyone’s interest to overcome the collective action problems inherent in dealing with market failures in the antimicrobial market through a global agreement.
The five operational recommendations describe actions countries could take to begin to implement such a deal.
Overview of the proposed Grand Bargain to Improve the Antimicrobial Market for Human Health
The Grand Bargain
A path to effective, affordable, and accessible antimicrobials
A Sustainable Access Hub
that ensures reliable access to and stewardship of essential antimicrobials and diagnostics where the market currently fails